enfuvirtide (Rx)

Brand and Other Names:Fuzeon
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, powder for reconstitution

  • 90mg/mL (reconstituted)
  • NOTE: 108mg vial reconstituted with 1.1mL sterile water delivers 90mg/mL
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HIV Infection

90 mg SC q12hr

Dosage Forms & Strengths

injection, powder for reconstitution

  • 90mg/mL (reconstituted)
  • NOTE: 108mg vial reconstituted with 1.1mL sterile water delivers 90mg/mL
more...

HIV Infection

<6 years: Safety and efficacy not established

6-16 years: 2 mg/kg SC q12hr; not to exceed 90 mg q12hr 

>16 years: 90 mg SC q12hr

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Interactions

Interaction Checker

and enfuvirtide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Difficult to separate from background regimen

            Multiple inj site rxn (98%)

            Pain & discomfort (96%)

            Erythema (91%)

            Induration (90%)

            Nodules and cysts (80%)

            Pruritis (65%)

            Ecchymosis (52%)

            Diarrhea (31%)

            Nausea (22%)

            Fatigue (20%)

            Periph. neuropathy

            Insomnia

            1-10%

            Difficult to separate from background regimen

            Asthenia

            Depression

            Pruritis

            Abdominal pain

            Anorexia

            Decreased appetite

            Weight loss

            Myalgia

            Cough

            Herpes simplex

            Influenza-like illness

            Pneumonia

            Sinusitis

            Lymphadenopathy

            Pancreatitis

            <1% (selected)

            Unstable angina

            Toxic hepatitis

            Renal failure

            Respiratory distress

            Guillain-Barre syndrome

            Hypersensitivity rxn

            Primary immune complex reaction

            Suicide attempt

            Postmarketing Reports

            Cutaneous amyloidosis at the injection site

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Use only in combination with other antiretrovirals

            Each injection should be in a different site than the previous one (upper arm, anterior thigh, abdomen)

            Monitor for signs and symptoms of pneumonia

            Low initial CD4+ T-cell count and high initial viral load

            Pulmonary disease, smoking

            If pt becomes pregnant, call Antiretroviral Pregnancy Registry 1-800-258-4263

            The possibility exists that this drug could result in a false-positive HIV test using (ELISA); use of a confirmatory test (Western blot) is advised

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; patients may develop an inflammatory response to indolent or residual opportunistic infection

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: Unknown whether enfuvirtide is excreted in milk; avoid in breastfeeding women; the CDC advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic peptide; inhibits fusion of HIV-1 with CD4+ cell membrane

            Combination use recommended

            Pharmacokinetics

            Half-Life: 3.8 hr

            Peak Plasma Time: 4-8 hr

            Peak Plasma Concentration: 4.59 +/- 1.5 mcg/mL

            AUC: 55.8 +/- 12.1 mcg.hr/mL

            Bioavailability: 84%

            Vd: 5.5L

            Protein Bound: 92%

            Metabolism: Hydrolysis

            Total Body Clearance: 21-29 mL/hr/kg

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            Administration

            SC Administration

            Inject SC into the upper arm, anterior thigh, or abdomen

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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